FDA.reportPublic FDA data

PR

Product NDC
72358-101
11-digit product format
723580101
Labeler code
72358
Product ID
72358-101_4229f4ae-8934-0e10-e063-6394a90a4185
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Amphp, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-01
Substance
MENTHOL
Active strength
.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72358-101-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72358-101-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72358-101-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72358-101-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72358-101-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72358-101-030efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
PR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293193Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f5b9e08-c445-4fac-e053-2a91aa0aa737Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
72358-101-032025-03-036f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032025-03-036f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-03-036f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-03-036f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032025-01-306f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032025-01-306f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-01-306f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-01-306f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-02-146f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-02-146f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-02-146f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-02-146f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-02-146f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-02-146f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-01-286f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-01-286f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-01-286f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-01-286f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-01-286f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-01-286f5b9e08-c445-4fac-e053-2a91aa0aa737

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72358-101-03PR20 g in 1 PACKETLOTION209
72358-101-04PR300 g in 1 BOTTLE, PLASTICLOTION3009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72358-101PR (MENTHOL) LOTION [AMPHP, INC]8Current NDC, Legacy NDC, 2 package rows20250305_6f5b9e08-c445-4fac-e053-2a91aa0aa737.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 85 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMenper Distributors Inc.ad940dc8-9403-44cf-aed3-6e538cbe488b2025-07-22WarningsExact identifier
application number: M017
Balsamo de Vaca MascuraMETHYL SALICYLATEMenper Distributors Inc.321b6f1f-c802-4b96-99d3-e77217da11a32025-07-22WarningsExact identifier
application number: M017
Abejas y Viboras Roll OnMETHYL SALICYLATEMenper Distributors Inc.bedf3b36-7def-099f-e053-2a95a90ac15b2025-07-22WarningsExact identifier
application number: M017
HealthWise Flexible 4% Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3869cc18-5494-6142-e063-6394a90a75e52025-07-22WarningsExact identifier
application number: M017
Arthcal 4% Lidocaine PatchesLIDOCAINEBeijing JUNGE Technology Co., Ltd.2e531194-67ad-c645-e063-6394a90a916c2025-07-22WarningsExact identifier
application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALMMENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITED206d8c1e-eb5b-4ec7-a54e-8defc9fb9d272025-07-22WarningsExact identifier
application number: M017
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
application number: M017
Mountain Ice Sports Pain ReliefMENTHOL, CAMPHORMountainside Medical Equipment, Inc.c1f5512c-67b1-4ff0-b1a5-616e883d436f2025-07-21WarningsExact identifier
application number: M017
Stopain Clinical Roll-OnMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.27703209-fdac-4620-a445-d89a84bc853d2025-07-21WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC9bac1869-8072-49bd-8568-a87a184d22002025-07-21WarningsExact identifier
application number: M017
Dr Kevin Khalili Pain Relief CreamMENTHOLDR. KHALILI LLC3a79b38c-9adc-60dd-e063-6394a90a5b302025-07-21WarningsExact identifier
application number: M017
ARTHRITIS PAIN RELIEFCAMPHOR, CAPSAICIN, METHYL SALICYLATEYUNNAN BAIYAO GROUP CO., LTD.671c57f0-3c6f-4416-bc81-f6930fef327b2025-07-21WarningsExact identifier
application number: M017
GoodSense Cooling Pain ReliefMENTHOLGeiss, Destin & Dunn, Inc2e5e1375-df07-9a43-e063-6394a90a99382025-07-20WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch CoolingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa7eae5dc-9db6-4bdf-9179-76060e75e0442025-07-18WarningsExact identifier
application number: M017
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
application number: M017
Aouiv 4% Lidocaine Numbing Cream4% LIDOCAINE NUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.3a221dd2-e945-bd0e-e063-6294a90a8fb92025-07-17WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293193menthol 0.5 % Topical LotionPSN6f5b9e08-c445-4fac-e053-2a91aa0aa7379
1293193menthol 5 MG/ML Topical LotionSCD6f5b9e08-c445-4fac-e053-2a91aa0aa7379
1293193menthol 0.5 % Topical LotionSY6f5b9e08-c445-4fac-e053-2a91aa0aa7379

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72358-101-0172358010101300 g in 1 TUBE (72358-101-01) 300 g2018-11-010000-00-00NoNoCurrent
72358-101-0272358010102100 g in 1 TUBE (72358-101-02) 100 g2018-11-010000-00-00NoNoCurrent
72358-101-037235801010320 g in 1 PACKET (72358-101-03) 20 g2018-11-010000-00-00NoNoCurrent
72358-101-0472358010104300 g in 1 BOTTLE, PLASTIC (72358-101-04) 300 g2018-11-010000-00-00NoNoCurrent